The Effect of Prematüre İnfant Oral Motor İntervention (PIOMI) and Chronobiological Approach to Feeding on Readiness to Feed, Transition to Total Oral Feeding, and Body Weight in Preterms
NCT ID: NCT07306793
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
54 participants
INTERVENTIONAL
2025-03-01
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Oral motor interventions applied in NICUs have been shown to accelerate the transition to oral feeding, increase weight gain, and shorten hospital stays in premature infants. Premature Infant Oral Motor Intervention (PIOMI) is one of the interventions applied in NICUs. Studies have shown that PIOMI is more effective than other interventions in this field. Furthermore, no negative side effects of PIOMI have been reported.
Breast milk is an ideal source of nutrition for the growth and development of preterm infants. It provides essential nutrients for the baby's growth and development, as well as containing biological cues that help regulate circadian rhythms. For the fetus, which has become accustomed to the mother's circadian rhythms during intrauterine life, it supports this transition process by providing similar cues after birth. The composition of breast milk can vary depending on gestational age, lactation stage, and pumping time. Differences are particularly observed between day and night breast milk in terms of circadian rhythms. Daytime milk contains higher levels of substances such as immune system-related nucleotides, interleukins, and antioxidants, while nighttime milk is rich in sleep-regulating components such as melatonin and tryptophan. This difference is important for the transmission of the mother's biological rhythms to the baby, contributing to the regulation of the baby's sleep-wake cycle and improving its environmental adaptation.
The chronobiological feeding model suggests that expressed breast milk be given in periods of day and night, or more specifically, in six-hour cycles, in accordance with the daily cycle. This approach aims to support the development of the infant's circadian rhythm through expressed breast milk in situations where breastfeeding is not possible. A review of the literature revealed no studies that combined PIOMI with chronobiological feeding. Therefore, this research was planned to determine the effects of oral motor intervention (PIOMI) and chronobiological feeding on feeding readiness, transition to total oral feeding and body weight in preterm infants hospitalized in the NICU.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PIOMI study group
Premature infant group undergoing Oral Motor Intervention.
PIOMI study group
Infants will be weighed at 8:30 AM wearing only a clean diaper, and the scale will be disinfected before and after each use. Preterm infants in this group will receive PIOMI treatment at their bedside for 5 minutes, once a day, 15 minutes before feeding times at 9:00 AM or 12:00 PM, for 14 days. Before starting the PIOMI treatment, the researcher will remove any jewelry and wash their hands hygienically. Following the PIOMI treatments, infants will be fed using the feeding method applied in the clinic, and this will be recorded. Infants will be monitored throughout their stay in the NICU.
Nutrition Study Group with a Chronobiological Approach
Group of infants fed using chronobiological approaches
Nutrition Study Group with a Chronobiological Approach
Newborns will be weighed at 8:30 a.m. wearing only a clean diaper, and the scale will be disinfected before and after each use. The researcher will provide training to the baby's mother on breast milk expression and storage. Breast milk storage bags and adhesive labels labeled "NIGHT MILK" and "DAY MILK" will be provided by the researcher. Mothers will be asked to express milk between 06:00 and 17:59, place it in a breast milk storage bag, attach the "DAY MILK" label, and write their name, surname, date, and time on it. For milk expressed between 18:00 and 05:59, they will place it in a breast milk storage bag, attach the "NIGHT MILK" label, and write their name, surname, date, and time on it, and bring their milk to the unit in this manner. Newborns in this group will be fed using breast milk that is chronobiologically matched.
No Intervention
Control group.
Control group
Newborns will be weighed at 8:30 AM wearing only a clean diaper, and the scale will be disinfected before and after each use. No procedures will be performed on these infants outside of the clinical routine. Infants will be fed using the same feeding method as in the clinic. Infants will be monitored throughout their stay in the NICU.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PIOMI study group
Infants will be weighed at 8:30 AM wearing only a clean diaper, and the scale will be disinfected before and after each use. Preterm infants in this group will receive PIOMI treatment at their bedside for 5 minutes, once a day, 15 minutes before feeding times at 9:00 AM or 12:00 PM, for 14 days. Before starting the PIOMI treatment, the researcher will remove any jewelry and wash their hands hygienically. Following the PIOMI treatments, infants will be fed using the feeding method applied in the clinic, and this will be recorded. Infants will be monitored throughout their stay in the NICU.
Nutrition Study Group with a Chronobiological Approach
Newborns will be weighed at 8:30 a.m. wearing only a clean diaper, and the scale will be disinfected before and after each use. The researcher will provide training to the baby's mother on breast milk expression and storage. Breast milk storage bags and adhesive labels labeled "NIGHT MILK" and "DAY MILK" will be provided by the researcher. Mothers will be asked to express milk between 06:00 and 17:59, place it in a breast milk storage bag, attach the "DAY MILK" label, and write their name, surname, date, and time on it. For milk expressed between 18:00 and 05:59, they will place it in a breast milk storage bag, attach the "NIGHT MILK" label, and write their name, surname, date, and time on it, and bring their milk to the unit in this manner. Newborns in this group will be fed using breast milk that is chronobiologically matched.
Control group
Newborns will be weighed at 8:30 AM wearing only a clean diaper, and the scale will be disinfected before and after each use. No procedures will be performed on these infants outside of the clinical routine. Infants will be fed using the same feeding method as in the clinic. Infants will be monitored throughout their stay in the NICU.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Whose vital signs and clinical condition have been stable for at least 24 hours,
* Whose APGAR score at 1 and 5 minutes (Activity-Pulse-Grimace-Appearance-Respiration) is 4 or higher.
Exclusion Criteria
* Infants with RDS,
* Infants diagnosed with asphyxia,
* Infants with intraventricular hemorrhage,
* Infants with Neonatal Withdrawal Syndrome,
* Infants with Fetal Alcohol Syndrome,
* Infants included in the study group who develop any complications or whose stable condition deteriorates during the follow-up period,
* Infants with feeding intolerance or who are interrupted from feeding for more than 48 hours,
* Infants who develop sepsis,
* Infants who develop necrotizing enterocolitis,
* Infants receiving mechanical ventilation support,
* Infants who receive narcotic analgesia or sedation,
29 Weeks
33 Weeks
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aydin Adnan Menderes University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Esra Bozkurt
PhD student
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aydın Adnan Menderes University, Faculty of Nursing, Department of Child Health and Disease Nursing
Aydin, Aydın, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Seher Sarıkaya Karabudak, Associate Professor
Role: CONTACT
Phone: +905054483703
Email: [email protected]
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Esra Bozkurt, PhD student
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Interventional trial
Identifier Type: -
Identifier Source: org_study_id